Harikanth Bayya

About Harikanth Bayya

About 16 years of experience in development of class II and class medical devices.…

Experience

1. Principal Software Quality Assurance Engineer

   Boston Scientific

   Mar 2009 — Present · Valencia, CA, US

   Lead Systems Software Quality for class Spinal Cord Stimulator and class II Radiofrequency Generator. Responsible for overseeing NPD design controls, determine safety classification, risk management, cybersecurity, patching and issue tracking. Collaborate with marketing, R&D, system, clinical, regulatory, global quality, complaints and PM teams. Responsible to analyze post market product complaints for NPD design input and improvement. Responsible for non-conforming events and prevention (NCEP) product investigation, root cause analysis and risk assessment. Responsible for overseeing usability and do use failure risk analysis. Responsible for overseeing design gates design inputs, design freeze and commercial readiness. Responsible to analyze safety of software issues identified in NPD change control board. Lead system software design validation to conform to design user needs.

Education

• Bradley University

  M.S.

• Nagarjuna University

  B.E

Skills

• Perl Script
• C/C++
• Perl
• Embedded Systems
• Unit Test
• Testing
• Integration
• C++
• Product Support Engineer
• Debugging
• Verification & Validation Test
• Software Quality Assurance
• Integration Test
• Test Automation
• Medical Devices
• Quality Assurance
• Cdma
• Wireless
• Gsm
• 3g
• Php
• Software Quality
• Integration Testing
• Python
• Mobile Devices
• Embedded Software
• Agile Metho
• Unit Testing
• Clearcase